1. Action A1 Prescription and adherence to treatment’
Enrica Menditto, PhD
CIRFF, Department of Pharmacy, University Federico II
Naples, April 1

2. AHA Strategic Implementation Plan: The Pillars

3. Action Group A1 Partners
The partners involved in the action come from several countries and the Italian stakeholders represent the 15%.
AIFA, Italian Medicines Agency represents one of the coordinator of the Action

4. Partners –members of Action Group A1
AIFA Consortium Coordinator
Andalusian Regional Ministry of Health and Social Welfare
Aston University UK
APSS, (Regional Health Provider Trento Province)
CIRFF, University of Naples
Department of Health and ConsumerAffairs of the Basque Government
Department of Health, Social Services and Public Safety Northern Ireland
Education, Health and Society Foundation Murcia
General Council of pharmacists Spain
GIRP European Association of Pharmaceutical Fullline Wholesalers, Brussels, Belgium
GSK
Healthy Ageing Network Northern Netherlands (HANNN)
Hospital de Getafe Spain
LST Universidad Politecnica Madrid Spain Coordinator
Medical university of Warsaw
Merck Serono
NHS Scotland Coordinator
University Coimbra
ParkinsonNet (Radboud University Nijmegen Medical Centre)
Perugia University
UCC Cork Ireland
University Coimbra Portugal
Veneto Region Italy

5. A1 Action Plan: General Objectives
ACTIONS
OBJECTIVES
Decision Support Tools
Dispensing & Prescribing
Interventions
Monitoring
1 – Improve Patient Adherence to Care Plans
Counseling & Education
Online services
Social networks
2 – Empower Patients
and care givers
Electronic prescription
Best-practices
Service models
Training
3 – Deliver improvements in the health care systems
Evidence
Guidelines
4 - Research and methodology
Data repositories
Networking
5 – Fostering Communication

6. Commitment Objectives
Action Plan and CIRFF Commitment Objectives
Action Plan
General Objectives
4. Research and methodology on adherence
5. Foster communication between different partners/actors in the healing and caring process to improve adherence foster communication
1. Improve patient adherence to care plans, including medication and healthy habits
CIRFF
Commitment Objectives
Develop a model to evaluate adherence on large population databases, especially focusing on:
Correlation between poor adherence and negative clinical outcomes
Optimal Proportion of Days Covered (PDC) threshold to assess adherence levels
Predictive factors of discontinuation
Cost-effectiveness of enhancing adherence levels
Develop a remote monitoring system of adherence levels based on prescription refill data in patients affected by chronic diseases
Develop a web-based platform to report and deliver information about adherence
State of Play
In timeframe Nov2012-Jan2013; Feb-Jun2013; Jul-Dec. We have collected data from regional Health Agency and created a population database ready to be used. We are currently defining cohorts of study, focusing on osteoporosis, diabetes, CHF, hypertension.
Consultation ongoing with partners.
Gathering platform design proposals
CIRFF
Commitment Partners
CIRFF, Department of Pharmacy, Federico II Unina
Lara Natale
Campania Region Health Care Authority
Maddalena Illario
Adelaide Ipppolito
Federico II University Hospital R&D Unit
Carolina Di Somma Department of
Clinical and Molecular Endocrinology
Federico II Unina
Guido Iaccarino
Department of Medicine and Surgery, University Hospital Salerno.

7. % of Pharmaceutical Expenditures
Rationale for prescription and
adherence action at regional level
Campania Region: Outpatient Pharmaceutical Comsumption
Age group
% of Population
% of Pharmaceutical Expenditures
DDD/1000 inh, die
All ages
100
Children (0-17 y)
16.5
3.3
2.0
Non elderly adults ( y)
67.5
46.5
44.6
Elderly (65 + y)
16.0
50.2
53.4
Source: CIRFF report Campania Region 2011

8. with chronic conditions % of Pharmaceutical Expenditure
Rationale for prescription and
adherence action at regional level
Age group
% of Population
with chronic conditions
% of Pharmaceutical Expenditure
All ages
27. %
83.1 %
Elderly (65 + y)
81.9 %
94.6 %
Chronic Disease and polytherapy
Source : Own elaboration based on CIRFF data.

9. Poor adherence: relevance
Time to Discontinuation* of Chronic Therapy Classes
* 30 days gap allowed
Source : Own elaboration based on CIRFF data.

10. Adherence improves health and reduces costs
The Opportunity:
Adherence improves health and reduces costs
Sorce: Sokol et al. 2005

11. Pharmacoepidemiology Resources utilization
Tools : administrative databases
observational model
Prescription
Pharmacoepidemiology
Drug utilization
Population database
Resources utilization
Costs
Effectiveness
Pharmacoeconomics

12. Our experiences - Antiosteoporosic drugs Antihypertensive therapy
The pharmacoeconomic impact of amlodipine use on coronary artery disease. de portu S, Menditto E, Scalone L, Bustacchini S, Cricelli C, Montovani LG. Pharmacological research 54 (2006)
Pharmacoeconomic consequences of amlodipine besylate therapy in patients indergoing PTCA. Rossetti F, De portu S, Menditto E, Scalone L, Bustacchini S, Cricelli C, Montovani LG. Pharmacological Research 53 (2006)
- Cost-effectiveness analysis of bisoprolol treatment for heart failure. Di Stasi F, Scalone L, De Portu S, Menditto E, Mantovani LG. Ital Heart J Dec;6(12):950-5
Lipid lowering therapy
Cammarota s, de Portu S, Riegler S, Citarella A, Menditto E, Mantovani LG. Predictors of non-persistence on statin treatments in Italy: A retrospective
Citarella A, Mantovani LG, Cammarota S, Menditto E, Riegler S, de Portu S. Pharmacoeconomic consequences of losartan therapy in patients undergoing Diabetes End-Stage Renal Disease. Value in Health 2009; Vol.12 (n. 7): A406.
Therapy for diabetes
The burden of hospitalization related to diabetes mellitus: a population-based study. De Berardis G, D'Ettorre A, Graziano G, Lucisano G, Pellegrini F, Cammarota S, Citarella A, Germinario CA, Lepore V, Menditto E, Nicolosi A, Vitullo F, Nicolucci A; DADA (Diabetes Administrative Data Analysis) Study Group. Nutr Metab Cardiovasc Dis Jul;22(7):
- Antiosteoporosic drugs
Casula M, Filippi A, Flacco E, Gambera M, Manzoli L, Menditto E, Orlando V, Piccinelli R, Tragni E, Catapano A. Assessment and potential determinats of compliance and persistence to anti-osteoporosis therapy in Italy. .
Iolascon g, Capaldo A, Orlando V, Menditto E. Persistence at one year of anti-osteoporotic drugs in southern italy: Analysis of administrative databases Clinical Cases 2013 in press
Miscellaneous on drug therapy
Proton pump inhibitors prescribing following the introduction of generic drugs. Cammarota S, Bruzzese D, Sarnelli G, Citarella A, Menditto E, Riegler S, Savino IG, Vozzella L, Piccinocchi G, Napoli L, Arpino G, Cuomo R. Eur J Clin Invest Oct;42(10):
P Comella, L Franco, R Casaretti, S de Portu, E Menditto. Emerging role of capecitabine in gastric cancer. Pharmacotherapy 2009;29(3):
Pharmaco-economic consequences of losartan therapy in patients undergoing diabetic end stage renal disease in EU and USA. de Portu S, Citarella A, Cammarota S, Menditto E, Mantovani LG.Clin Exp Hypertens. 2011;33(3):174-8.
Menditto E, Citarella A, Cammarota S, de Portu S, S.Mantovani L G, Riegler S. Prevalence, incidence and persistence of antidepressant drug prescribing in the Italian general population: retrospective database analysis, Value in Health 2009; Vol.12 (n. 7): A353.
Miscellaneous on methods
Menditto E,  Citarella A, Cammarota S, Sabatella C,  Riegler S. L’utilizzo dei database amministrativi per la ricerca di base e la programmazione sanitaria: l’esperienza dell’ASL Salerno 2. GIFF 2009; 2 (1) :
Menditto E, Citarella A. Valutazione economica dello studio IDEAL. Farmeconomia e percorsi terapeutici 2007; 8 (Suppl 2): 23-26
de Portu S, Menditto E, Mantovani LG. Valutazione economica dello studio CARDS, aggiornamenti. Farmeconomia e percorsi terapeutici 2007; 8 (Suppl 2): 36-40
de Portu S, Cammarota S, Menditto E, Mantovani LG. Valutazione economica dello studio AVERT Farmeconomia e percorsi terapeutici 2007; 8 (Suppl 2): 31-35

13. Measuring adherence
Pharmacoepidemiology and drug safety, 2006

14. Our Action : Adherence Monitoring System (AMS)
The use of administrative databases to monitor adherence allows to detect in real-life scenario:
- drug exposure in a population over time
levels of adherence to medication
predictive factors of discontinuation- establish risk definitions to tailor interventions
correlation between poor adherence and negative clinical outcomes
cost-effectiveness of enhancing adherence levels

15. Pharmaceutical Records Hospital Discharge Records
Data Banks and Information Systems
Patients Registry
Patient encrypted Code
Birth date
Gender
Withdrawal date
Pharmaceutical Records
Patient encrypted Code
Drug AIC code
Drug ATC code
Prescription date
Dispensation date
Amount of boxes
Hospital Discharge Records
Patient encrypted Code
Hospitalization date
Discharge date
Admission type
Discharge type
DRG
Main diagnosis
Concomitant diagnosis
Data Set CIRFF
Patient encrypted Code–details – Pharmaceutical prescriptions – Hospitalizations

16. Adherence Monitoring System
ALERTT DB
Reporting

17. Expected results Improving quality of care for patients
Drug comsumption razionalization
Improving knowledge about adherence issues
Improving interaction among patients, physicians and pharmacists

18. “Drugs don't work in patients who don't take them.”
—C. Everett Koop, MD
Naples, April
Enrica Menditto